Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent. The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan. Ninety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules or placebo for 12 weeks and evaluated every 4 weeks. The main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.
The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent.
The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan.
Ninety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules (500 mg) or placebo capsules, which were identical in appearance and packaged in identical-looking containers. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. Compliance was assessed by counting the remaining capsules at each follow-up visit.
At each follow-up visit, subjects were asked to grade the overall response and questioned regarding adverse events. The objective or main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glutathione Group | Experimental | Subjects were randomised to receive Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. |
|
| Placebo Group | Placebo Comparator | Subjects were randomised to receive Placebo capsules, which were identical in appearance and packaged in identical-looking containers with the Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutathione | Drug | Oral glutathione capsule (500 mg), were taken once daily by the subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Spot UV at 4 weeks | Total reduction (improvement) of spot UV | 4 weeks |
| Change from Baseline Spot Polarization at 4 weeks | Total reduction (improvement) of spot polarization | 4 weeks |
| Change from Baseline Skin Tone at 4 weeks | Improvement of skin tone | 4 weeks |
| Change from Baseline Spot UV at 8 weeks | Total reduction (improvement) of spot UV | 8 weeks |
| Change from Baseline Spot Polarization at 8 weeks | Total reduction (improvement) of spot polarization | 8 weeks |
| Change from Baseline Skin Tone at 8 weeks | Improvement of skin tone | 8 weeks |
| Change from Baseline Spot UV at 12 weeks | Total reduction (improvement) of spot UV | 12 weeks |
| Change from Baseline Spot Polarization at 12 weeks | Total reduction (improvement) of spot polarization | 12 weeks |
| Change from Baseline Skin Tone at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Improvement at 4 weeks | Subjects were asked to grade the overall response using rating scale with a multiple-choice question:
Note: The higher improvement represents a better outcome. | 4 weeks |
| Adverse events at 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Universitas Indonesia | Jakarta Pusat | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34840651 | Derived | Sitohang IBS, Anwar AI, Jusuf NK, Arimuko A, Norawati L, Veronica S. Evaluating Oral Glutathione Plus Ascorbic Acid, Alpha-lipoic Acid, and Zinc Aspartate as a Skin-lightening Agent: An Indonesian Multicenter, Randomized, Controlled Trial. J Clin Aesthet Dermatol. 2021 Jul;14(7):E53-E58. Epub 2021 Jul 1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005978 | Glutathione |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo oral tablet | Drug | Placebo oral capsule were taken once daily by the subjects. |
|
Improvement of skin tone |
| 12 weeks |
Adverse events related to therapy |
| 4 weeks |
| Subjective Improvement at 8 weeks | Subjects were asked to grade the overall response using rating scale with a multiple-choice question:
Note: The higher improvement represents a better outcome. | 8 weeks |
| Adverse events at 8 weeks | Adverse events related to therapy | 8 weeks |
| Subjective Improvement at 12 weeks | Subjects were asked to grade the overall response using rating scale with a multiple-choice question:
Note: The higher improvement represents a better outcome. | 12 weeks |
| Adverse events at 12 weeks | Adverse events related to therapy | 12 weeks |